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Protocol # 20-601

Status

Recruiting

Description

This study includes a Dose Escalation Part to identify the recommended combination dose (RCD) and a Dose Expansion Part to further evaluate efficacy and safety. The primary objectives: Dose Escalation: To assess the safety and tolerability of patritumab deruxtecan (U3-1402) and osimertinib in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC) with an EGFR exon 19 deletion or L858R mutation with tumor progression after treatment with osimertinib, and to determine the recommended combination dose (RCD). Second-Line Dose Expansion Arm 1 and Arm 1b: To assess the preliminary antitumor activity of patritumab deruxtecan and osimertinib in subjects with locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation with tumor progression after treatment with osimertinib. Note: One or both of the study arms may open with one or two distinct dosing schedules. Second-Line Dose Expansion Arm 2: To assess the preliminary antitumor activity of patritumab deruxtecan monotherapy in subjects with locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation with tumor progression after treatment with osimertinib. First-Line Dose Expansion: To assess the safety and tolerability of patritumab deruxtecan and osimertinib in subjects with locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation without prior systemic treatment for locally advanced or metastatic disease.

Condition

  • Non-Small Cell Lung Cancer (NSCLC)

Interventions

  • Patritumab deruxtecan
  • Patritumab deruxtecan
  • Osimertinib
  • Osimertinib
  • Patritumab deruxtecan
  • Patritumab deruxtecan
  • Osimertinib

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Dose Escalation: Incidence of Dose-limiting Toxicities (DLT), Treatment-emergent Adverse Events (TEAE), Serious Adverse Events (SAE), Adverse Events of Special Interest (AESI)
  • Second-line Dose Expansion: Objective Response Rate (ORR)
  • First-line Dose Expansion: Incidence of Treatment-emergent Adverse Events (TEAE), Serious Adverse Events (SAE), Adverse Events of Special Interest (AESI)

Secondary Outcome:

  • Dose Escalation and First-line Dose Expansion: Objective Response Rate (ORR)
  • Second-line Dose Expansion: Objective Response Rate (ORR)
  • Dose Escalation, Second-line Dose Expansion, and First-Line Dose Expansion: Duration of Response (DoR)
  • Dose Escalation, Second-line Dose Expansion, and First-line Dose Expansion: Disease Control Rate (DCR)
  • Dose Escalation, Second-line Dose Expansion, and First-line Dose Expansion: Time to Response (TTR)
  • Dose Escalation, Second-line Dose Expansion, and First-line Dose Expansion: Progression-free Survival (PFS)
  • Dose Escalation, Second-line Dose Expansion, and First-line Dose Expansion: Overall Survival (OS)
  • Second-line Dose Expansion: Incidence of Treatment-emergent Adverse Events (TEAE), Serious Adverse Events (SAE), Adverse Events of Special Interest (AESI)
  • Dose Escalation, Second-line Dose Expansion, and First-line Dose Expansion: Proportion of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) and Proportion of Participants Who Have Treatment-emergent ADA
  • Dose Escalation, Second-line Dose Expansion, and First-line Dose Expansion: Pharmacokinetic Parameter Maximum Concentration (Cmax)
  • Dose Escalation, Second-line Dose Expansion, and First-line Dose Expansion: Pharmacokinetic Parameter Time to Maximum Concentration (Tmax)
  • Dose Escalation, Second-line Dose Expansion, and First-line Dose Expansion: Pharmacokinetic Parameter Area Under the Concentration-Time Curve (AUC)

Enrollment

252

Study Start Date

June 11, 2021

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Daiichi Sankyo, Inc.

Source

Daiichi Sankyo, Inc.

Official title

A Phase 1 Open-Label Study of Patritumab Deruxtecan in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic EGFR-mutated Non-Small Cell Lung Cancer (NSCLC)

Clinicaltrials.gov Identifier

NCT04676477

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.